Not so very long ago, vaccine development and manufacturing was something of a backwater in pharmaceutical R&D and manufacturing programs. Now, suddenly it's at the forefront. After all, Wyeth's (Madison, NJ) vaccine program was one of the attractions making it an acquisition target for Pfizer (New York). What's more, several analyst reports place vaccines as the highest growth sector of biopharmaceutical programs. What's happened lately to catapult vaccines into the spotlight?

A few things. The outbreak in recent years of two widespread and potentially fatal strains of flu elevated influenza from medical inconvenience to public-health emergency. Second, well-publicized delays in producing vaccine against the H1N1 pandemic strain in 2009 highlighted how ineffectual is the traditional manufacturing paradigm in responding to sudden large-scale outbreaks of influenza. Both events placed new pressures on manufacturers to find novel, more responsive, more scalable methods for vaccine production.

Indeed just this past August, the President's Council of Advisors on Science and Technology (PCAST) issued a report to the president on ways to reengineer the entire influenza vaccine manufacturing enterprise to meet the challenges of a pandemic influenza outbreak. At the same time, the Department of Health and Human Services (HHS) issued a report describing how government and industry could work together to tackle pandemic influenza, and according to a recent press briefing by HHS Secretary Kathleen Sebelius, the Obama administration proposed a $2 billion strategy to create a more "nimble and flexible" system for responding to novel pathogens (see Washington Report).

But switching to new manufacturing paradigms will not come easily or cheaply. For one thing, the traditional platform already has regulatory approval. But FDA released a guidance in February 2010 that paves the way for novel formulations and manufacturing approaches. Even if regulatory roadblocks were removed, however, there remains the stark economic reality that traditional influenza vaccine is a low-margin business, which leaves little incentive for innovation. Notes Rahul Singhvi, president and CEO of Novavax (Rockville, MD), "If you looked at the vaccine landscape today, it would be tough to say that influenza is a good area to go into given that five companies dominate the market and that the vaccine is basically a commodity." The trick for companies looking to move the technology forward is to find a solution as economical as it is effective.